BEUDAMED
    FDA Recall Terminated

    BD Exacta 8.5 Fr Percutaneous Sheath Introducer Tray

    Recall: Z-0628-05 · Initiated January 10, 2005

    Recall

    Recall Number
    Z-0628-05
    Event Number
    30864
    Firm
    Becton Dickinson Infusion Therapy
    FEI Number
    1710034
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 10, 2005
    Posted
    March 18, 2005
    Terminated
    April 12, 2005
    Address
    9450 S State St, Sandy, UT, 84070

    Description

    BD Exacta 8.5 Fr Percutaneous Sheath Introducer Tray

    Reason

    Various procedure trays and kits may have an insufficient seal, thus compromising sterility.

    Action

    Customers were contacted by telephone and by letters dated 01/10/05.

    Distribution

    Domestic distribution: WI. International distribution: Puerto Rico, Virgin Islands. There were no military or VA facilities.

    Quantity

    15 units